Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There is no information on toxicity to reproduction available.

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In accordance with Annex XI, section 3.2 (b) of Regulation (EC) No 1907/2006 (REACH), a reproduction toxicity study can be omitted since the substance is manufactured and used under strictly controlled conditions and no significant worker exposure occurs (for a detailed justification see CSR chapter 5.11, 9, 10 and IUCLID chapter 7.1).


Effects on developmental toxicity

Description of key information
There is no information on toxicity to reproduction available. 
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

In accordance with Annex XI, section 3.2 (b) of Regulation (EC) No 1907/2006 (REACH) a reproduction toxicity study can be omitted since the substance is manufactured and used under strictly controlled conditions and no significant worker exposure occurs (for a detailed justification see CSR chapter 5.11, 9, 10 and IUCLID chapter 7.1).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
There are no data available on toxicity to reproduction for the test item. The substance is not considered to be classified for reproductive toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.